Phase 3 Protocol of Total Androgen Suppression and Radiation Therapy (RT) vs. TAS and RT Followed by Chemotherapy with Paclitaxel, Estramustine, and Etoposide for Localized, High Risk, Prostate Cancer.

摘要

Summary of Protocol Objectives: The primary objectives were to assess the relative efficacy of the combination of androgen suppression (AS) plus radiation therapy (RT) followed AS vs. AS plus RT followed by chemotherapy (CT) plus AS in high risk, unfavorable prognosis prostate cancer (PCa) population. In order to measure the efficacy of the treatments the endpoints being evaluated were overall survival, disease free survival, local control and freedom from distant metastasis. Differences in toxicities between the two treatments were also going to be evaluated. The RTOG 9902 investigators hypothesize that adjuvant CT would improve the survival rate of high-risk PCa when used in combination with RT and AS. Methods: The purpose and methods were reviewed and approved by the local IRB. The voluntary and full informed consent of participants was obtained prior to study procedures. Volunteer participants who met eligibility criteria were stratified, enrolled and randomized as per protocol. In brief, eligibility criteria included men with high risk non metastatic prostate cancer histologically confirmed with PSA level of 20- 100ng/mL and a Gleason score > 7, stage T2 or greater. Volunteer participants were randomized into one of two treatments. RT began 8 weeks after androgen suppression treatment and followed weekly by their radiation oncologist during the RT, every 3 months for two years, then every 6 months for three years and yearly after that for the remainder of the participant s natural life. Results: Study was locally approved on November 2000 and assigned number FDG20010007H, receiving 10 continuing approval before IRB oversight was transferred to Wilford Hall (WHMC) under protocol number FWH20110083H. IRB oversight was transferred back DGMC in May 2012. This study opened nationally in Jan 2000 and prematurely closed to accrual in Oct 2004 with a total of 397 participants (380 eligible); 2 from DGMC. The protocol has been deemed terminated by national RT.